Subject: NIH GUIDE - RFA DK-92-08 - V20(41) 11/01/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Mon, 04 Nov 91 14:43 EST

Hi Paul,
   # 4 to be posted to the NIH Listserver.  Please post as:
      RFADK-92-08.911101
                        Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA DK9208 DK-92-08 P1O1 *****************************************
 
GENETICS AND KIDNEY MATURATION, WITH AN EMPHASIS ON POLYCYSTIC KIDNEY
DISEASE
 
RFA:  DK-92-08
 
P.T. 34; K.W. 1002019, 1002027, 1002004, 1002008, 0710075, 0785095
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date:  December 16, 1991
Application Receipt Date:  January 22, 1992
 
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of
the  National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) announces a Request for Applications (RFA) on the above
subject.  The mechanism of support will be limited to the
investigator-initiated research grant (R01) funding mechanism.
 
BACKGROUND
 
Progress in preventing and treating diseases of the kidney will be
enhanced when fundamental understandings of pathogenesis are
achieved.  The cross-fertilization of the disciplines of genetics and
molecular biology, cell chemistry and biology, immunology,
physiology, microbiology, and pathology have resulted in new and
extremely useful experimental tools that allow scientists to address
and seek answers to questions at a fundamental level.  The regulation
of cellular growth is one of the most exciting areas of kidney
research and investigators have identified several growth factors and
determined their exact chemical composition.  The powerful tools of
molecular biology (i.e., polymerase chain reaction and in situ
hybridization techniques) offer further promise for expanding
knowledge about the regulatory genes that control differentiation and
encode the signals that establish the precise topographical patterns
essential to the function of the fully developed kidney.  Fostering
further research at the molecular level to address cellular and basic
mechanisms, beginning with the developing kidney, may raise the
possibility of new breakthroughs that will lead to effective
treatment of kidney diseases and/or their prevention.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of Healthy People 2000, a
PHS-led national activity for setting priority areas.  This RFA,
Genetics and Kidney Maturation, with an Emphasis on Polycystic Kidney
Disease, is related to the priority area of diabetes and chronic
disabling conditions.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).
 
RESEARCH GOALS AND SCOPE
 
This special grant program will support fundamental research.  An
emphasis of this initiative, however, is to foster extensive
collaboration between individuals in the basic sciences, including
biochemistry, cell biology, embryology, endocrinology, molecular
biology, genetics, nutrition, pathology, pharmacology, renal
physiology and pathophysiology.  It is the intent of this
solicitation to engage investigators with diverse research interests
who wish to apply their technologies and expertise in elucidating and
extending the current understanding of the genetic aspects of kidney
disease and the cellular and integrated mechanisms in the developing
kidney.
 
The following are some suggested directions that might be taken to
achieve the objectives of this solicitation:
 
o  Basic studies on the physiology and pathophysiology of the
developing normal and genetically-affected kidney. For example, the
cellular and molecular aspects of glomerular, tubular, interstitial,
and vascular development in these circumstances require further
elucidation.  Examples include the cellular derivation of the
glomerular mesangium, composition and characteristics of the
embryonic mesangial matrix and endothelial cells, events involved in
cellular communication and transformation in renal epithelium, and
mechanisms by which differentiating and growing cells influence and
are influenced by the extracellular matrix.
 
o  Assessment of function of the developing kidney, both normal and
genetically-affected by:  (a) developing new methodology that could
uncover abnormal renal function at an earlier stage, prior to
detection by the existing methodology; and (b) assessing and
comparing endocrine function of the normal and genetically affected
developing kidney.
 
o  Research on genetic or developmental disorders of the kidney,
including the pathophysiology of kidney diseases that develop in the
pediatric age group and may become clinically evident in adolescence
and adulthood. Examples include, polycystic kidney and other cystic
diseases, renal dysplasias or hypoplasias, congenital nephrotic
syndrome, and congenital obstructive nephropathy or uropathy, and
diseases more prevalent in minority populations.
 
The above are examples only and are not all-inclusive.
 
ELIGIBILITY
 
Research grant applications may be submitted by foreign and domestic,
non-profit and profit-making, organizations and institutions, State
and local governments and their agencies, and eligible agencies of
the Federal Government.  Applications from women and minorities are
encouraged.
 
MECHANISM OF SUPPORT
 
Applications may be submitted for the traditional,
investigator-initiated research project grant (R01). Under this
mechanism, the applicants will plan, direct, and conduct the research
programs.  The project period during which the research will be
conducted must adequately reflect the time required to accomplish the
stated goals and be consistent with the policy for grant support.
Support will be provided up to five years (renewable for subsequent
periods) subject to the availability of funds and progress achieved.
 
REVIEW PROCEDURES AND CRITERIA
 
Upon receipt, applications will initially be reviewed by the Division
of Research Grants (DRG) for completeness. Incomplete applications
will be returned to the applicant without further consideration.
Applications will be reviewed by NIDDK program staff for
responsiveness to the objectives of the RFA.  If an application is
considered unresponsiveness, the applicant will be contacted and
given an opportunity to withdraw the application or have it
considered as an unsolicited grant application to the NIH.  If the
application submitted in response to this RFA is substantially
similar to a grant application already submitted to the NIH for
review, but has not yet been reviewed, the applicant will be asked to
withdraw either the pending application or the new one.  Simultaneous
submission of identical applications will not be allowed, nor will
essentially identical applications be reviewed by different review
committees.  Therefore, an application cannot be submitted in
response to this RFA that is essentially identical to one that has
already been reviewed.  This does not preclude the submission of
substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous
critique.
 
Review Procedures
 
Applications in response to this RFA will be reviewed in accordance
with the NIH peer review procedures.  Applications will first be
reviewed for scientific and technical merit by an Initial Review
Group that will be convened by the Division of Research Grants.  This
group will be composed of primarily of non-Federal scientific
consultants.  The applications will then be reviewed by the National
Diabetes and Digestive and Kidney Disease Advisory Council.  If the
number of applications is large compared to the number of awards to
be made, the NIH may conduct a preliminary scientific peer review to
eliminate those applications that are clearly not competitive.  The
NIH will administratively withdraw from competition those
applications judged to be noncompetitive and notify the applicant and
institutional business official.
 
Review Criteria
 
Review criteria include the extent of relevance and/or contribution
of the proposed research to the overall goals and objectives of the
RFA; the novelty, originality, and feasibility of the approach; the
training, experience, and research competence of the investigator(s);
the adequacy of the experimental design; the suitability of the
facilities; and the appropriateness of the requested budget to the
work proposed.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH policy is that applicants for clinical research grants and
cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders
and conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.
 
The composition of the proposed study population must be described in
terms of gender and racial/ethnic group, together with a rationale
for its choice.  In addition, gender and racial/ethnic issues should
be addressed in developing a research design and sample size
appropriate for the scientific objectives of the study.  This
information should be included in the Form PHS 398 in Section 2, A-D
of the Research Plan and summarized in Section 2, E. Human Subjects.
 
Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics). The rationale for
studies on single minority population groups should be provided.
 
For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.
 
The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.
 
For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.
 
If the required information is not contained within the application,
the application will be returned.
 
Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific questions(s) addressed and the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.
 
All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.
 
FUNDS AVAILABLE
 
For FY 1992, $2.0 million in total costs per year will be committed
to fund applications submitted in response to this RFA.  It is
anticipated that 10 to 12 awards will be made.  However, this funding
level is dependent upon the receipt of a sufficient number of
applications of high scientific merit.  The total project period for
applications submitted in response to this RFA may not exceed five
years.  Although this program is provided for in the financial plans
of NIDDK, the award of grants pursuant to the RFA is contingent upon
the appropriated funds for this purpose.  In order to help meet NIDDK
goals for managing the cost of biomedical research, applicants must
limit their requests to not more than $160,000 in direct costs for
the first year.  With respect to post-award administration, the
current policies and requirements that govern the research grant
programs of the NIH will prevail.
 
METHOD OF APPLYING
 
Letter of Intent
 
Prospective applicants are encouraged to submit an optional letter of
intent, that includes the title of the proposed project and
identification of all participating institutions.  Such letters are
requested only for the purpose of obtaining an indication of the
number and scope of applications to be received.  A letter of intent
is not binding, and it will not enter into the review of the
application subsequently submitted.  This letter is to be received no
later than December 16, 1991, and is to be sent to:
 
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 406
Bethesda, MD  20892
 
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the
proposed research.  In such a case, a letter of agreement from either
the GCRC program director or Principal Investigator must be included
with the application.
 
Applications must be submitted using form PHS 398 (rev. 10/88),
"Application for Public Health Service Grant," available in the
business or grants office of most academic or research institutions
and from the Office of Grants Inquiries, Division of Research Grants,
National Institutes of Health, 5333 Westbard Avenue, Room 449,
Bethesda, MD  20892, telephone 301/496-7441.  In order to assure
proper identification of the application, line 2 of the application
face page should state, "DK-92-08, Genetics and Kidney Maturation"
and check the "YES" box.
 
Timetable
 
A letter of intent is requested by December 16, 1991.
Applications must be received by January 22, 1992.  Any
applications not received by this date will be considered
ineligible for this special solicitation.
 
APPLICATION      INITIAL       COUNCIL      EARLIEST
RECEIPT          REVIEW        REVIEW       START DATE
 
Jan. 22, 1992  March 1992     June 1992     July 1, 1992
 
Send the original and four copies to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH  GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING
IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH.
APPLICANTS WHO USE  EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO
FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS.  THE
ADDRESS FOR THE WESTWOOD BUILDING IS:
 
5333 Westbard Avenue
Bethesda, MD  20816
 
To expedite the review, send two copies of the application to:
 
Robert D. Hammond, Ph.D.
Chief, Review Branch
Division of Extramural Program Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 406
Bethesda, MD  20892
 
INQUIRIES
 
M. James Scherbenske, Ph.D.
Program Director, Renal Physiology/Cell Biology
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-04
Bethesda, MD  20892
Telephone:  (301) 496-7458
 
Gladys H. Hirschman, M.D.
Program Director, Chronic Renal Diseases
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Bethesda, MD  20892
Telephone:  (301) 496-8218
 
For fiscal and administrative matters, contact:
 
Mrs. Helen Y.S. Ling
Grants Management Specialist
Grants Management Branch, DEA
National Institute of Diabetes and Digestive, and Kidney Diseases
Westwood Building, Room 639
Bethesda, MD  20892
Telephone:  (301) 496-7467
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.849.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99- 158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CRF Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.